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FDA 510(k)

AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK)

K-Number: K022680 · 2002-11-01

ApplicantAzog, Inc.
Decision Date2002-11-01
Product CodeDHA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK) is the device name listed in this FDA 510(k) record. The listed applicant is Azog, Inc.. It received FDA 510(k) clearance on 2002-11-01 under 510(k) number K022680. The device is classified under product code DHA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK)?

AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK) is a medical device that received FDA 510(k) clearance on 2002-11-01. The listed applicant is Azog, Inc.. The 510(k) number is K022680.

When did AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK) receive FDA 510(k) clearance?

AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK) received FDA 510(k) clearance on 2002-11-01, under 510(k) number K022680.

Who is the listed applicant for AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK)?

The FDA 510(k) record lists Azog, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK)?

The FDA product code for AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK) is DHA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Azog, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K041748AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND MIDSTREAM)K022681AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST (DEVICE OR CASSETTE)

Related Devices (Code: DHA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233581VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackOrtho Clinical DiagnosticsK223690iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)Shenzhen Yhlo Biotech Co., Ltd.K230937Alinity i Total ß-hCG Reagent Kit, GLP systems TrackAbbott LaboratoriesK230790Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-seriesAbbott LaboratoriesK221990Access Total ßhCG (5th IS)Beckman Coulter, Inc.K212221Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay AnalyzerDiazyme Laboratories, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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